FDA 510(k)

ID NOW Influenza A & B 2

N.º K: K232775 · 2023-10-10

SolicitanteAbbott Diagnostics Scarborough, Inc.

Fecha de decisión2023-10-10

Código de productoOCC

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

ID NOW Influenza A & B 2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics Scarborough, Inc.. It received FDA 510(k) clearance on 2023-10-10 under 510(k) number K232775. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ID NOW Influenza A & B 2?

ID NOW Influenza A & B 2 is a medical device that received FDA 510(k) clearance on 2023-10-10. The listed applicant is Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K232775.

When did ID NOW Influenza A & B 2 receive FDA 510(k) clearance?

ID NOW Influenza A & B 2 received FDA 510(k) clearance on 2023-10-10, under 510(k) number K232775.

Who is the listed applicant for ID NOW Influenza A & B 2?

The FDA 510(k) record lists Abbott Diagnostics Scarborough, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ID NOW Influenza A & B 2?

The FDA product code for ID NOW Influenza A & B 2 is OCC.

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Otros registros que enlistan a Abbott Diagnostics Scarborough, Inc. como solicitante

K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 K250273BinaxNOW COVID-19 Ag Card K243518BinaxNOW™ COVID-19 Antigen Self Test K221925ID NOW COVID-19 2.0 K220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 K191534ID NOW Influenza A & B 2

Ver todos los 7 dispositivos →

Dispositivos relacionados (Código: OCC)

K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.K210234cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.